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therapeutic melatonin
therapeutic melatonin is a Small molecule drug developed by Radiation Therapy Oncology Group. It is currently in Phase 2 development. Also known as: Circadin, Melatonin, Melaxen.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | therapeutic melatonin |
|---|---|
| Also known as | Circadin, Melatonin, Melaxen |
| Sponsor | Radiation Therapy Oncology Group |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Effect of 1% Melatonin Gel Versus Calcium Hydroxide as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Periapical MMP-9 Levels in Patients With Necrotic Pulp. (NA)
- A Study of Melatonin Concentration During Lactation
- Melatonin for Treatment of Delirium in Critically Ill Adult Patients (PHASE2)
- PICU-related Sleep and Circadian Dysregulation Pilot Study (NA)
- Studying Melatonin and Recovery in Teens (NA)
- Effect of Esketamine on Postoperative Sleep in Postmenopausal Women (NA)
- The Effect of Dexmedetomidine Infusion Alone Versus the Combination of Dexmedetomidine and Melatonin on Reduction of Post-operative Delirium (POD) After Open Brain Surgeries (PHASE4)
- Melatonin Versus Placebo for Bipolar Disorder (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- therapeutic melatonin CI brief — competitive landscape report
- therapeutic melatonin updates RSS · CI watch RSS
- Radiation Therapy Oncology Group portfolio CI
Frequently asked questions about therapeutic melatonin
What is therapeutic melatonin?
Who makes therapeutic melatonin?
Is therapeutic melatonin also known as anything else?
What development phase is therapeutic melatonin in?
Related
- Manufacturer: Radiation Therapy Oncology Group — full pipeline
- Also known as: Circadin, Melatonin, Melaxen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing